| CTRI Number |
CTRI/2024/12/078590 [Registered on: 26/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yoga and psycho-somatic health of students preparing for competitive exam |
|
Scientific Title of Study
|
Efficacy of yoga practices on physiological and
psychological variables of students preparing for
competitive exams: a waitlist randomized
controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meera Soni |
| Designation |
PhD Scholar |
| Affiliation |
S-VYASA University |
| Address |
Prashanti Kuteeram, S-VYASA deemed to be University, J. Bingipura, kallu ballu post, jigani Hobli, KARNATAKA
Prashanti Kuteeram, S-VYASA deemed to be University, J. Bingipura, kallu ballu post, jigani Hobli, KARNATAKA
Bangalore
KARNATAKA
560105
India |
| Phone |
9783119332 |
| Fax |
|
| Email |
meerayoga2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Narayana Behera |
| Designation |
Professor and Dean |
| Affiliation |
S-VYASA University |
| Address |
Prashanti Kuteeram, S-VYASA deemed to be University, J. Bingipura, kallu ballu post, jigani Hobli, KARNATAKA
Prashanti Kuteeram, S-VYASA deemed to be University, J. Bingipura, kallu ballu post, jigani Hobli, KARNATAKA
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
9986448015 |
| Fax |
|
| Email |
narayanbehera@svyasa.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Nair |
| Designation |
Assistant Professor |
| Affiliation |
S-VYASA University |
| Address |
Prashanti Kuteeram, S-VYASA deemed to be University, J. Bingipura, kallu ballu post, jigani Hobli, KARNATAKA
Prashanti Kuteeram, S-VYASA deemed to be University, J. Bingipura, kallu ballu post, jigani Hobli, KARNATAKA
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
9632164777 |
| Fax |
|
| Email |
rajeshnair@svyasa.edu.in |
|
|
Source of Monetary or Material Support
|
| Pradhyuman Kumar Soni
593,Barkat nagar,tonk phatak,jaipur, Rajasthan,India-302015
pradhyuman2104@gmail.com |
|
|
Primary Sponsor
|
| Name |
Meera Soni |
| Address |
Prashanti Kutiram, S-VYASA University, Jigani, Bangalore, Karnataka-560105 |
| Type of Sponsor |
Other [Individual] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Poornima Soni |
Sweet Red Rose senior secondary school |
31-A Vikas Nagar, Rajani vihar, 21, Mandir marg, near Chitrakoot,
Heerapura,Heerawala,
Jaipur
Jaipur
RAJASTHAN |
7340339330
poornimasoni.99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) - SVYASA |
Approved |
| Institutional Ethics Committee (IEC) - SVYASA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Students undergoing exam related stress. (Exams/tests related to admission for professional courses) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Group doing regular activities,
Exercises,
Walking etc
Frequency:5 days / week
Duration: 3 months |
| Intervention |
Yoga practices |
Yoga Asanas (postures)
Pranayama practices
Deep Relaxation Techniques
Session duration: 45Minutes,
Frequency:5 days/week,
Duration: 3 months |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy students aged 16-20 years.
2. Currently preparing for competitive exams like JEE or NEET.
3. Enrolled in a recognized coaching institute for exam preparation.
4. Willing to participate in a three-month yoga intervention program.
5. Able to provide informed and parental consent for those under 18.
6. Physically fit to perform yoga practices (as determined by a pre-participation health
screening). |
|
| ExclusionCriteria |
| Details |
1. Students with diagnosed major psychiatric disorders (e.g., clinical depression, anxiety
disorders, bipolar disorder).
2. Those currently under medication that could affect the cortisol level and psychological
variables.
3. Students with physical disabilities or medical conditions that prevent safe participation
in yoga practices.
4. Regular practitioners of yoga, meditation, or other mind-body interventions (more than
once a week).
5. Participation in any other stress management program or psychological intervention
during the study period.
6. History of substance abuse.
7. Inability to understand or comply with study procedures and requirements. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Salivary cortisol
Stress
Anxiety
Depression |
Two (pre and post) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mind wandering
Self-Esteem
Sleep Quality
Emotional well-being
|
Two (pre and post) |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study evaluates the impact of yoga practices on both physiological and psychological variables in students preparing for competitive exams. Using a waitlist randomized controlled trial, it measures salivary cortisol (a stress hormone), stress, anxiety, and depression, as well as mind wandering, self-esteem, sleep quality, and emotion regulation. The goal is to assess whether yoga can reduce stress, improve mental health, boost self-esteem, regulate emotions, and promote better sleep, ultimately helping students manage the pressures of intense exam preparation. |